FDA 510(K) K073491, EEG-1100A SWITCH BOX
FDA 510(K) K073491, EEG-1100A SWITCH BOX
Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K073491
Device Name EEG-1100A SWITCH BOX
Applicant NIHON KOHDEN AMERICA, INC.
Regulation Number 882.1400
Classification Product Code OLV
Subsequent Product Code GWQ
Date Received 12/12/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
Total pages: 124
Fully redacted pages: 56
Content pages: 68
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